Details for New Drug Application (NDA): 078556
✉ Email this page to a colleague
NDA 078556 describes DIGOXIN, which is a drug marketed by Amici, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Novitium Pharma, Rising, Stevens J, and Sun Pharm Inds Inc, and is included in seventeen NDAs. It is available from twenty-seven suppliers. Additional details are available on the DIGOXIN profile page.
The generic ingredient in DIGOXIN is digoxin. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.
The generic ingredient in DIGOXIN is digoxin. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 078556
| Tradename: | DIGOXIN |
| Applicant: | Impax Labs |
| Ingredient: | digoxin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078556
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIGOXIN | digoxin | TABLET;ORAL | 078556 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-9811 | 0115-9811-01 | 100 TABLET in 1 BOTTLE (0115-9811-01) |
| DIGOXIN | digoxin | TABLET;ORAL | 078556 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-9811 | 0115-9811-02 | 500 TABLET in 1 BOTTLE (0115-9811-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.125MG | ||||
| Approval Date: | Jul 20, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Jul 20, 2009 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
